Dataset Information

Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT).

ABSTRACT: BACKGROUND:Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. METHODS/DESIGN:The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01901796.

SUBMITTER: Kingston D

PROVIDER: S-EPMC4015853 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT).

Kingston Dawn D Austin Marie-Paule MP Hegadoren Kathy K McDonald Sheila S Lasiuk Gerri G McDonald Sarah S Heaman Maureen M Biringer Anne A Sword Wendy W Giallo Rebecca R Patel Tejal T Lane-Smith Marie M van Zanten Sander Veldhuyzen SV

Trials 20140306

<h4>Background</h4>Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being.<h4>Meth ...[more]

PMID: 24597683

Similar Datasets

Project description:BackgroundMost people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care.MethodsIn an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation.DiscussionTo the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany.Trial registrationClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

Project description:The lives of persons living with mental illness are affected by psychological, biological, social, economic, and environmental factors over the life course. It is therefore unlikely that simple preventive strategies, clinical treatments, therapeutic interventions, or policy options will succeed as singular solutions for the challenges of mental illness. Persons living with mental illness receive services and supports in multiple settings across the health care continuum that are often fragmented, uncoordinated, and inadequately responsive. Appropriate assessment is an important tool that health systems must deploy to respond to the strengths, preferences, and needs of persons with mental illness. However, standard approaches are often focused on measurement of psychiatric symptoms without taking a broader perspective to address issues like growth, development, and aging; physical health and disability; social relationships; economic resources; housing; substance use; involvement with criminal justice; stigma; and recovery. Using conglomerations of instruments to cover more domains is impractical, inconsistent, and incomplete while posing considerable assessment burden. interRAI mental health instruments were developed by a network of over 100 researchers, clinicians, and policy experts from over 35 nations. This includes assessment systems for adults in inpatient psychiatry, community mental health, emergency departments, mobile crisis teams, and long-term care settings, as well as a screening system for police officers. A similar set of instruments is available for child/youth mental health. The instruments form an integrated mental health information system because they share a common assessment language, conceptual basis, clinical emphasis, data collection approach, data elements, and care planning protocols. The key applications of these instruments include care planning, outcome measurement, quality improvement, and resource allocation. The composition of these instruments and psychometric properties are reviewed, and examples related to homeless are used to illustrate the various applications of these assessment systems.

Project description:Anecdotal evidence suggested that waiting times within the older adults community mental health team (OA CMHT) had been increasing over time. An assessment and evaluation was indicated to ensure best quality care was provided for patients. A comparison was made between waiting times in January to December 2011 compared with August 2013 to July 2014. In 2011 the mean number of days until initial assessment from the point of referral was 12 days for routine cases, and 3.6 days for urgent cases. The re-audit showed the number of days increased to 15.89 days for routine cases, and 9.81 days for urgent cases. Contributory factors were reviewed, and it was felt that to address this problem, a duty worker role was necessary. The role of the duty worker was divided into triaging and allocating work. The triaging process was to ensure all urgent cases were highlighted early and acted upon. The duty worker's role was also to gather sufficient information from the referrer, to reduce the risks of inadequate knowledge delaying assessment. In addition, the allocating process required the duty worker to designate a clinician in charge of the case upon receipt of referral. This ensured that clinicians were able to offer the earliest possible appointment slot for the initial assessment, and thus reduce waiting times. Following implementation, findings from September 2014 to February 2015 showed an improvement in average waiting times, as well as an improvement in the percentage of assessments reviewed within previously set standards. For routine reviews, the mean time until assessment was 10.68 days. For urgent reviews, the mean time until initial assessment was 6.8 days. However, it was noted that majority of urgent reviews were still not being reviewed in time. The outcomes of this study demonstrated an improvement of both waiting times, and percentage of patients being seen within set standards following a single intervention. In the current climate of cost efficiency savings, it is important for services to continue to find ways to streamline and improve upon current practices, to ensure the best outcome for patients.

Project description:Background: Epilepsy is one of the most common chronic paediatric conditions. Children and young people with epilepsy are at a significantly higher risk of developing mental health problems relative to the general population, yet the majority of these problems are unrecognised and under-treated in clinical practice. Although there is little epilepsy-specific guidance as to what interventions to use, researchers suggest there is no reason why clinicians should not be using the evidence base. Given the poor prognosis of untreated mental health difficulties, this cohort study sought to identify what psychological treatment young people with epilepsy with mental health needs receive in routine practice. Methods: Participants were children and young people aged 3 to 18 attending paediatric neurology clinics. The parents of those children who met threshold for impairing symptoms on the Strengths and Difficulties questionnaire were asked to complete the Development and Well-being Assessment (DAWBA), an online clinical assessment designed to generate psychiatric diagnoses. Participants who met clinical threshold for a disorder according to the DAWBA were provided with a bespoke measure asking questions regarding their experience with treatment for mental health support. Results: 16 of the 46 parents who completed the DAWBA reported that they had experienced previous or current support for their child's mental health difficulties. The mental health support offered to families was highly variable, inadequate and often not clearly compliant with existing UK National Institute for Health and Clinical Excellence (NICE) guidelines for mental health treatment in children and young people. Conclusions: The present study demonstrates the inconsistency and inadequacy of mental health provision for children and young people with epilepsy. Future work should explore reasons for the treatments offered failing to adhere to existing guidance for mental health difficulties in children, as well as possible solutions to this.

Project description:BACKGROUND:Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress are significant risk factors that may have detrimental long-term developmental consequences for the affected children. Negative outcomes are seen on a range of areas such as physical and mental health, educational and labor market success, social network and establishing of family. Secure attachment is associated with optimal outcomes in all developmental domains in childhood, and both insecure and disorganized attachment are associated with a range of later problems and psychopathologies. In disadvantaged populations insecure and disorganized attachment are common, which points to the need of identifying early risk and effective methods of addressing such problems. This protocol describes an experimental evaluation of an indicated group-based parental educational program, Circle of Security-Parenting (COS-P), currently being conducted in Denmark. METHODS/DESIGN:In a parallel randomized controlled trial of two intervention groups this study tests the efficacy of COS-P compared to Care as Usual (CAU) in enhancing maternal sensitivity and child attachment in a community sample in the City of Copenhagen, Denmark. During the project a general population of an estimated 17.600 families with an infant aged 2-12 months are screened for two known infant mental health risks, maternal postnatal depression and infant social withdrawal. Eligible families (N?=?314), who agree to participate, will be randomly allocated with a ratio of 2:1 into the COS-P intervention arm and into CAU. Data will be obtained at inclusion (baseline) and at follow-up when the child is 12-16 months. The primary outcome is maternal sensitivity. Secondary outcomes include quality of infant attachment, language, cognitive and socioemotional development, family functioning, parental stress, parental mentalizing and maternal mental wellbeing. DISCUSSION:The potential implications of the experimental evaluation of an indicated brief group-based parenting educational program to enhance parental sensitivity and attachment are discussed. TRIAL REGISTRATION:ClinicalTrials.govID: NCT02497677 . Registered July 15 2015.

Project description:BackgroundDepression and anxiety frequently coexist with chronic musculoskeletal pain and can negatively impact patients' responses to standard orthopedic treatments. Nevertheless, mental health is not routinely addressed in the orthopedic care setting. If effective, a digital mental health intervention may be a feasible and scalable method of addressing mental health in an orthopedic setting.ObjectiveWe aimed to compare 2-month changes in mental and physical health between orthopedic patients who received a digital mental health intervention in addition to usual orthopedic care, those who received usual orthopedic care only (without a specific mental health intervention), and those who received in-person care with a psychologist as part of their orthopedic treatment plan.MethodsIn this single-center retrospective cohort study involving ancillary analysis of a pilot feasibility study, 2-month self-reported health changes were compared between a cohort of orthopedic patients who received access to a digital mental health intervention (Wysa) and 2 convenience sample comparison cohorts (patients who received usual orthopedic care without a specific mental health intervention and patients who received in-person care with a psychologist as part of their orthopedic treatment plan). All patients were 18 years or older and reported elevated symptoms of depression or anxiety at an orthopedic clinic visit (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression or Anxiety score ≥55). The digital intervention was a multi-component mobile app that used chatbot technology and text-based access to human counselors to provide cognitive behavioral therapy, mindfulness training, and sleep tools, among other features, with an emphasis on behavioral activation and pain acceptance. Outcomes of interest were between-cohort differences in the 2-month longitudinal changes in PROMIS Depression and Anxiety scores (primary outcomes) and PROMIS Pain Interference and Physical Function scores (secondary outcomes).ResultsAmong 153 patients (mean age 55, SD 15 years; 128 [83.7%] female; 51 patients per cohort), patients who received the digital mental health intervention showed clinically meaningful improvements at the 2-month follow-up for all PROMIS measures (mean longitudinal improvement 2.8-3.7 points; P≤.02). After controlling for age and BMI, the improvements in PROMIS Depression, Pain Interference, and Physical Function were meaningfully greater than longitudinal changes shown by patients who received usual orthopedic care (mean between-group difference 2.6-4.8 points; P≤.04). Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04).ConclusionsPatients who received a digital mental health intervention as part of orthopedic care reported greater 2-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.

Dataset Information

Publications

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets